FDA Registration
Active
🇸🇪 Sweden
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head
Reg #: 3015232217
·
FEI: 3015232217
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- ELEKTA SOLUTIONS AB
- Registration Number
- 3015232217
- FEI Number
- 3015232217
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hagaplan 4
- City
- STOCKHOLM
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K160627
Owner / Operator
- Firm Name
- ELEKTA AB
- Operator Number
- 8030893
- Address
- Hagaplan 4
- City
- Stockholm
- State
- SE-AB
- Postal Code
- SE11368
- Country
- SE
US Agent
- Business Name
- Elekta Inc.
- Contact Name
- Thomas Valentine
- Address
- 400 Perimeter Center Terrace, Suite 50
- City
- ATL
- State
- GA
- ZIP
- 30346
- Country
- US
- [email protected]
- Phone
- 404 7972537
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2025-05-16 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2025-05-16 |
| Couch, Radiation Therapy, Powered | JAI | Class 2 | Radiology | No | 2025-05-16 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2025-05-16 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2025-05-16 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | Class 2 | Radiology | No | 2025-05-16 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2025-05-16 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2025-05-16 |
Proprietary Names
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head
Establishment Types
Export Device to the United States But Perform No Other Operation on Device